Acute Effect of Lorazepam on Brain Activity Measured by Magnetoencephalograpy (MEG) and Electroencephalography (EEG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Orasi Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Orasi Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01272778
First received: January 5, 2011
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

This placebo-controlled crossover study is intended to measure the effect of four doses of lorazepam on brain activity measured by magnetoencephalography (MEG) and electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple cognition testing on 16 healthy male volunteers. On each of five study days subjects will be randomized to receive either 0.2, 0.5, 1.0 or 2.0 mg lorazepam or placebo. Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to medication administration and 2, 4, and 6 hours after medication administration. Blood samples to determine medication levels and cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. Data will be analyzed to identify changes in brain activity compared to baseline and placebo administration using both standard approaches and the Orasi Synchronous Neural Interaction® (SNI) test. This study will test the hypothesis that dose-response changes in brain functional activity can be accurately measured by MEG/EEG in healthy volunteer subjects after single, acute doses of lorazepam.


Condition Intervention
Healthy Subjects
Drug: Lorazepam
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Acute Effect of Four Doses of Lorazepam on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction™ Test

Resource links provided by NLM:


Further study details as provided by Orasi Medical, Inc.:

Primary Outcome Measures:
  • Correlated Brain Activity using MEG and SNI analysis [ Time Frame: 2 hours after dosing with lorazepam ] [ Designated as safety issue: No ]
    The identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of ascending doses of lorazepam compared to pre-medication baseline and placebo


Secondary Outcome Measures:
  • Correlated Brain Activity using MEG and standard analyses [ Time Frame: 2 hours after dosing with lorazepam ] [ Designated as safety issue: No ]
    Standard frequency-domain analysis of the MEG data to identify and quantify medication-induced changes in signal power in particular frequency bands associated with brain functional activity


Estimated Enrollment: 16
Study Start Date: October 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lorazepam 0.2 mg
All subjects receive lorazepam 0.2 mg in this crossover design.
Drug: Lorazepam
Oral capsule, 0.2 mg, single acute dose
Experimental: Lorazepam, 0.5 mg
All subjects receive lorazepam 0.5 mg in this crossover design.
Drug: Lorazepam
oral capsule, 0.5 mg, single acute dose
Experimental: Lorazepam, 1.0 mg
All subjects receive lorazepam 1.0 mg in this crossover design.
Drug: Lorazepam
oral capsule, 1.0 mg, single acute dose
Experimental: Lorazepam, 2.0 mg
All subjects receive lorazepam 2.0 mg in this crossover design
Drug: Lorazepam
oral capsule, 2.0 mg, single acute dose
Placebo Comparator: Sugar pill
All subjects receive a sugar pill in this crossover design.
Drug: Placebo
oral capsule, single acute dose

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is male between 18 and 35 years of age at the time of screening.
  • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  • Subject is a non-smoker.
  • Subject is judged to be in good health based on medical history and brief physical examination and electrocardiogram.
  • Subject has normal or corrected to normal visual and auditory acuity.
  • Subject agrees to refrain from caffeine 24 hours prior to and then throughout each Study Day.
  • Subject agrees to refrain from using alcohol for 48 hours prior to and then throughout each Study Day.

Exclusion Criteria:

  • Subject has a diagnosis of a significant neurological condition including Alzheimer's disease, Parkinson's disease, vascular dementia, Lewy body dementia or frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, or severe traumatic brain injury.
  • Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
  • Subject has a history of seizures, epilepsy, stroke, peripheral neuropathy, head trauma with persistent post-concussive symptoms, ADHD, dyslexia or other clinically significant neurological disease or cognitive impairment.
  • Subject has a lifetime or current history of alcohol or substance abuse/dependence.
  • Subject has a history of multiple or severe allergies, or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs. This includes a documented or subject-verified allergy.
  • Subject had an MRI 2 weeks prior to Study Day 2.
  • Subject has metal braces or pacemaker that may interfere with the MEG scan.
  • Subject is unable to complete the MEG scan procedure.
  • The investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272778

Contacts
Contact: Christina Kay, MA 847-981-3570 christina.kay@abbhh.net
Contact: Donnell Carmichael, PsyD 847-981-5771 donnell.carmichael@abbhh.net

Locations
United States, Illinois
Alexian Brothers Neurosciences Institute Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Christina Kay, MA    847-981-3570    christina.kay@abbhh.net   
Contact: Donnell Carmichael, PsyD    847-981-5771    donnell.carmichael@abbhh.net   
Principal Investigator: Concetta Forchetti, MD, PhD         
Sponsors and Collaborators
Orasi Medical, Inc.
Investigators
Principal Investigator: Concetta Forchetti, MD, PhD Alexian Brothers Neurosciences Institute
  More Information

No publications provided

Responsible Party: Todd Verdoorn, PhD, Chief Scientific Officer, Orasi Medical, Inc.
ClinicalTrials.gov Identifier: NCT01272778     History of Changes
Other Study ID Numbers: ADE-LDR 10-02
Study First Received: January 5, 2011
Last Updated: January 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lorazepam
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014